Xarelto rivaroxaban regulatory update

Johnson & Johnson's Janssen Research & Development LLC subsidiary said it received a second complete response letter from FDA for an sNDA for Xarelto rivaroxaban to reduce the risk of cardiovascular events in patients with acute coronary syndrome (ACS). Janssen said it is evaluating the letter and will respond to FDA's questions. FDA issued the first complete response letter for Xarelto for the indication last June. Details of both letters were not disclosed. J&J said an sNDA for Xarelto to reduce the risk of stent thrombosis in ACS patients is still under FDA review. ...